Dietary Seaweed and Early Breast Cancer: A Randomized Trial

NCT01663792 | Completed

• 1 other identifier: DAMD-17-98-1-8207
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Could daily consumption of seaweed help explain lower postmenopausal breast cancer (BC) incidence and mortality rates in Japan? This small proof of principle clinical trial was designed to test the idea that the same amount of seaweed normally eaten in Japan would induce metabolic changes when given to non-seaweed consuming healthy postmenopausal American women. The participants were given 10 capsules a day (about 1 tablespoon) for 3 months. During the first month the capsules contained placebo, the second month seaweed, and the third month placebo. We collected blood and urine samples after each treatment period and tested for changes in protein expression that might be related to consuming seaweed.

Conditions

Seaweed Associated Changes in Healthy Subjects

Keywords

urokinase receptor; protein expression; seaweed (Undaria pinnatifida)

Outcome Measures

Primary Outcomes (2)

• Urinary urokinase receptor concentration

  ELISA test for uPAR concentration

  3 months

• Surface Enhanced Laser Desorption/Ionization-Time Of Flight-Mass Spectrometry (SELDI-TOF-MS)identification of urinary and serum protein changes

  SELDI-TOF-MS was used to measure urinary and serum protein changes

  3 months

Secondary Outcomes (1)

• Urinary iodine concentrations

  3 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

5 g/d placebo (maltodextrin)in 10 500-mg capsules for 1 month

Other: Placebo

Seaweed

EXPERIMENTAL

Seaweed (Undaria pinnatifida) given orally in ten 500-mg capsules for 1 month

Other: Seaweed

Placebo2

PLACEBO COMPARATOR

5 g/d placebo in 10 500-mg capsules for one month

Other: Placebo2

Interventions

Seaweed OTHER

Ten 500-mg capsules to be taken orally each day for 1 month

Also known as: Undaria pinnatifida

Seaweed

Placebo OTHER

Ten 500-mg capsules to be taken orally each day for 1 month

Also known as: Maltodextrin

Placebo

Placebo2 OTHER

Ten 500-mg capsules to be taken orally each day for 1 month

Also known as: Maltodextrin

Placebo2

Eligibility Criteria

• Age: 45 Years - 68 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Postmenopausal (verified by follicle stimulating hormone (FSH) \[23.0-116 mIU/ml\]
• Omnivorous eating habits (including meat and dairy products more than twice per week)
• Limit alcoholic intake to ≤ 1 drink (12 g alcohol)/week

You may not qualify if:

• No allergies to seaweed, soy, shellfish or iodine
• No current use of tobacco
• No hormone replacement therapy
• For BC survivors, no chemotherapy or radiation treatments within the preceding 6 months
• No history of cancer (other than BC or squamous cell skin cancer) within the previous 20 years
• No current gastrointestinal disorders or diabetes
• No oral antibiotics taken in the previous 3 months

Sponsors & Collaborators

• University of South Carolina: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

University of South Carolina Cancer Research Center

Columbia, South Carolina, 29208, United States

Location

Related Publications (31)

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MeSH Terms

Interventions

maltodextrin

Study Officials

• Jane Teas, Ph.D.

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: October 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (1)